Uses of Aliskiren and Hydrochlorothiazide:

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Aliskiren and Hydrochlorothiazide?

• If you have an allergy to aliskiren, hydrochlorothiazide, or any other part of aliskiren and hydrochlorothiazide.
• If you are allergic to aliskiren and hydrochlorothiazide; any part of aliskiren and hydrochlorothiazide; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a sulfa allergy.
• If you are taking any of these drugs: Cyclosporine, dofetilide, or itraconazole.
• If you are not able to pass urine.
• If you have high blood sugar (diabetes) or kidney disease and are taking certain drugs for high blood pressure or your heart. Talk with your doctor.
• If you are breast-feeding. Do not breast-feed while you take aliskiren and hydrochlorothiazide.

This is not a list of all drugs or health problems that interact with aliskiren and hydrochlorothiazide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take aliskiren and hydrochlorothiazide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Aliskiren and Hydrochlorothiazide?

• Tell all of your health care providers that you take aliskiren and hydrochlorothiazide. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how aliskiren and hydrochlorothiazide affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you have high blood sugar (diabetes), aliskiren and hydrochlorothiazide may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Check your blood pressure as you have been told.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take aliskiren and hydrochlorothiazide.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with aliskiren and hydrochlorothiazide.
• Watch for gout attacks.
• If you have lupus, aliskiren and hydrochlorothiazide can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• If you are 65 or older, use aliskiren and hydrochlorothiazide with care. You could have more side effects.

How is this medicine (Aliskiren and Hydrochlorothiazide) best taken?

Use aliskiren and hydrochlorothiazide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
• Take aliskiren and hydrochlorothiazide at the same time of day.
• Keep taking aliskiren and hydrochlorothiazide as you have been told by your doctor or other health care provider, even if you feel well.
• This medicine may cause you to pass urine more often. To keep from having sleep problems, try not to take too close to bedtime.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Any skin change.
• This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting aliskiren and hydrochlorothiazide. Call your doctor right away if you have these signs.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Aliskiren and Hydrochlorothiazide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling tired or weak.
• Cough.
• Diarrhea.
• Flu-like signs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Aliskiren and Hydrochlorothiazide?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about aliskiren and hydrochlorothiazide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.